NDC | 43749-430-12, 43749-430-13 |
Set ID | 4defc910-1f4b-4a87-8bdd-9d71d8cadd93 |
Category | HUMAN OTC DRUG LABEL |
Packager | Unipack, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
- Drug Facts
-
Uses
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily relieves burning and shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
- Warnings
- Ask a doctor or pharmacist before use if you are
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor
- If pregnant or breastfeeding
- Keep out of reach of children
-
Directions: Adults
Directions: Adults
-when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.
-detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
-hold suppository with rounded end up
-as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"
-slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose from wrapper
-insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
-children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Label
-
INGREDIENTS AND APPEARANCE
AVEDANA HEMORRHOIDAL
hemorrhoidal rectal suppositories suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-430 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 88.5 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE .26 g in 100 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) .02 g in 100 g PROPYLPARABEN (UNII: Z8IX2SC1OH) .02 g in 100 g MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) 11.2 g in 100 g Product Characteristics Color white Score Shape BULLET Size 32mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43749-430-13 2 in 1 CARTON 09/17/2017 1 NDC:43749-430-12 12 g in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 09/18/2014 Labeler - Unipack, Inc. (009248480) Establishment Name Address ID/FEI Business Operations Unipack, Inc. 009248480 manufacture(43749-430)